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Cloth Masks, Medical-Grade and Respirators - What Are They?

Cloth Masks, Medical-Grade and Respirators - What Are They?

If you've been mask-shopping any time in the past year or two, you're probably already aware of how complicated the process can be. Not only are there countless counterfeit and subpar devices on sale, but even official devices often fall into categories that aren't clear. As a result, terms like cloth mask, surgical mask, face covering, medical-grade and respirator are regularly thrown around. 

 

However, it's tough to find an exact definition of what each of these terms signifies. Compounding to the issue is that manufacturers can combine many of these terms. For example, it's possible to find medical-grade surgical masks or medical-grade respirators. These terms are often used as marketing buzzwords. However, they do relate to the performance and purpose of a device.

 

For that reason, it's essential to know what each term means and how it applies to the performance and use-case of a mask. If you're unsure what exactly constitutes a cloth mask, face covering, medical-grade mask or otherwise, this article is for you. We will discuss not only the similarities but also the differences between each form of mask. 

 

Further, we will also take a look at the purpose of each device. With highly varying performance and uses, there are some devices that are substantially better than others in given situations. After reading this article, you will know the differences between these devices and when they should (or should not) be used.


Face Coverings

Face coverings are the broadest type of respiratory protection device, and the term is recent, only becoming extremely common during the COVID-19 pandemic. In short, a face covering is any device that covers the nose and mouth of the wearer (1). 

 

Almost anything that covers the wearer's lower face can be considered a face covering with such a broad definition. However, when the term 'face covering' is used by governments and officials, it usually refers to the lowest filtration devices such as bandanas.

 

While bandanas provide minimal protection, some innovative multi-layer face covers provide significantly more protection. However, this leads to an issue as there is so much variance between the performance of different face coverings.

 

While higher-quality face covers will have multiple layers and fit well, there are no specifications for face coverings. However, the U.K government does recommend against using bandanas, scarves, or religious garments as face coverings. 

 

Face coverings are not PPE (personal protective equipment), and they are not designed to protect the wearer from airborne hazards. For this reason, face coverings sit at the bottom of this list regarding the protection they provide. 

 

Further, face coverings don't need to adhere to any manufacturing standard or quality program. This means that face coverings can vary greatly, and they shouldn't be relied upon to protect the wearer. 

 

For this reason, we should not use face coverings except as a last resort. At the dawn of the pandemic, many governments and organisations recommended them. However, this was due to the lack of higher-quality filtration devices such as surgical masks and respirators. A face covering is better than nothing, but they perform far worse than devices manufactured and certified according to performance standards.

 

Now that surgical masks are easy to find and cheap to purchase, they are better. They provide (usually) higher filtration and are manufactured to adhere to standards. Respirators are a step above and will give even further protection. While some people may still be donning homemade face coverings, using bandanas or otherwise, it's highly recommended to move to PPE in high-risk situations.

 

It is also worth noting that while face coverings provide some level of filtration against inhaled and exhaled respiratory particles, they are ineffective against ultrafine and fine particles that make up the majority of air pollution.

 

When it comes to COVID-19, many countries have banned the use of face coverings due to their low performance. In their place, medical-grade masks or even respirators are required. However, more on those soon!

 

  1. https://www.gov.uk/government/publications/face-coverings-when-to-wear-one-and-how-to-make-your-own/face-coverings-when-to-wear-one-and-how-to-make-your-own

Cloth Masks

Cloth mask is another term used for non-PPE masks that have not been manufactured to adhere to any standard. Cloth masks are a form of face covering, and you will often hear the two phrases used interchangeably. Similarly to face coverings, cloth masks can vary significantly in filtration efficacy, and while they are better than no mask, medical-grade surgical masks and respirators offer superior performance.

 

Also similarly to face coverings, cloth masks were popularised at the start of the pandemic due to PPE shortages. As a result, many clothing companies started to produce fabric masks, and many people even created homemade masks. During the production shortages, these were a fantastic stop-gap as they provided significantly more protection than not wearing a mask. 

 

However, with the production shortages now over and PPE in far greater supply, cloth masks are not the best choice. In addition, the CDC has stated that cloth masks provide less protection than surgical masks and respirators (1), and these devices should be used instead of cloth masks when more protection is needed or desired.

 

While some individuals may prefer to wear cloth masks in low-risk situations due to their (usually) better comfort, they should not be worn in high-risk situations. In these situations, a more performant device will provide far superior protection.

 

Further, the filtration of a cloth mask can vary greatly depending on the materials used to construct the device and the number of filtration layers present. With that being said, respirators will provide better protection than even the best cloth masks.

 

Some cloth masks include filter inserts that can be used to add more performant filtration media. However, the fit of the cloth mask and implementation of the filter insert can lead to leaks which will drop the device's performance. Therefore, even cloth masks with filter inserts are second in performance to medical-grade surgical masks and respirators (2).

 

In a recent study (2), researchers compared a range of cloth masks to a standard N95 respirator and a 3M 1836 surgical mask. This study found that out of 10 cloth masks, all performed worse than the surgical mask in their default state.

 

Interestingly, the researchers also found that adding a nylon layer for filtration allowed some cloth masks to surpass the surgical mask's performance. However, none of the cloth masks outperformed the 3M surgical mask when it also had an added nylon layer.

 

This study is an excellent example of why cloth masks were a good short-term replacement for better devices during the early days of the pandemic. They provide better protection than nothing, but at the same time, they perform far worse than a medical-grade surgical mask. Since surgical masks and respirators are now very easy to pick up, cloth masks are no longer recommended.

 

It's also important to keep in mind that cloth masks are now banned in many countries worldwide. While some governments still allow the use of such masks, many countries require PPE devices such as surgical masks or respirators to be used.

 

  1. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html
  2. https://www.medrxiv.org/content/10.1101/2020.04.17.20069567v2.full.pdf

Surgical Masks

Although surgical masks have been commonplace in some industries for years, it was once again the pandemic that popularised them for most people. Usually, these masks come in blue or white, and they look like folded pieces of paper. They have two ear loops and often include a wire nosepiece for fitting around the bridge of the wearer's nose.

 

These masks are designed to catch expelled droplets from the wearer. These droplets are often quite large, and surgical masks can catch the majority of water-based particles and prevent them from becoming airborne.

 

The terminology surgical mask is somewhat confusing because these devices can also be labelled as isolation masks, dental masks, or medical procedure masks (1). While many individuals refer to these devices as face masks, it's essential to differentiate between the two because not all face masks are certified and regulated as surgical masks.

 

Surgical masks are regulated under 21 CFR 878.4040 in the U.S and, as the name implies, are designed to be used by surgeons and dentists. However, they are very limited in the protection they offer. 

 

The way that surgical masks are designed means that they don't seal and often have many leaks around the edges of the mask. On top of this, the filter material itself is not designed to filter fine and ultrafine particles. 

 

As such, these devices provide limited protection. They are designed to catch splashes and large-particle droplets. While they can be somewhat effective at this, they only offer minimal protection against fine particles - including airborne viral particles. 

 

For this reason, surgical masks should also never be used against air pollution, and they also offer limited filtration against allergens. A respirator is essential if you are looking for protection against airborne particles, especially fine and ultrafine particles.

 

Although surgical masks only loosely fit, you can purchase a brace, creating a part-seal. While these braces can significantly increase the fit of a mask, and greatly reduce leaks, they shouldn't be relied on. Even with these braces, it's difficult to seal a surgical mask correctly, and there are likely to be leaks in the device.

 

For this reason, surgical masks sit above cloth masks and face covers regarding the protection they provide. However, due to their lacking seal, loose fit, and lower quality filtration media, they don't perform as well as respirators. 

 

With that being said, surgical masks tend to be more comfortable than respirators. This is because they have lower breathing resistance and don't seal. While a respirator is far better in high-risk situations, surgical masks may be a good choice when comfort is more important.

 

  1. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-face-masks-and-barrier-face-coverings#:~:text=N95%20respirators%20and%20surgical%20masks,NIOSH)%20also%20regulates%20N95%20respirators.

Medical Grade

Medical grade is another confusing term that is often thrown around. This particular term is so confusing because both surgical masks and respirators can be medical grade. However, while any certified surgical mask is medical-grade, not all respirators are medical-grade.

 

A lot of the confusion has arisen due to recent COVID-19 masking rules. Many countries have banned cloth masks and face covers in public areas and have now mandated 'medical-grade masks or better'.

 

This is ambiguous because, technically, most respirators are not medical-grade. However, when this statement is said, it's usually okay to don respirators as they are more performant devices than medical-grade surgical masks (which is usually what these statements refer to). 

 

So, what is a medical-grade mask? A medical-grade mask is a device that has been certified to be used in medical scenarios. While the exact standards that these devices adhere to vary from region to region, medical-grade masks will typically adhere to ASTM F2100 or EN14683. 

 

These standards define specifications that each device must perform. ASTM F2100 and EN14683 measure bacterial filtration resistance, particle filtration resistance (ASTM F2100), fluid resistance, airflow resistance (breathability), and more.

 

The biggest confusion comes when we start to define medical-grade vs respirators. The problem is that these two types of devices are certified by different authorities (in the U.S). Medical-grade devices are certified by the FDA, whereas respirators are certified under NIOSH. 

 

NIOSH respirator testing is more stringent regarding particle filtration efficiency, but it doesn't test the fluid resistance, flame resistance, or bacterial filtration efficiency of a device. Therefore, for a NIOSH-certified respirator to become a medical-grade respirator, it must undergo testing by NIOSH (to become a respirator) and testing by the FDA (to become medical-grade). 

 

Therefore, while a medical-grade surgical mask provides some level of protection against particles, bacteria and fluid, a medical-grade respirator offers these protections on top of > 95% filtration efficiency. Further, unlike surgical masks, a well-fitting respirator will seal and provide far superior protection against fine and ultrafine particles. 

 

As with surgical masks, we should not use medical-grade devices for protection against air pollution unless the device in question is also a respirator. Respirators have to undergo stringent testing against fine and ultrafine particles, and these are the most dangerous particles when it comes to air pollution.

 

While the term medical-grade isn't complicated, there have been many mixed messages during the pandemic. The terms surgical mask and medical-grade seem to be considered interchangeable by many due to the similarities. However, some significant differences need to be considered.


Respirators (Filtering Facepiece Respirator)

Respirators are the devices that offer the most protection on this list. These devices are designed to filter the majority of both fine and ultrafine particles, and they are far more effective than surgical masks. However, a medical-grade respirator is best for anyone using a respirator in a medical scenario.

 

Respirators are devices certified by NIOSH in the United States and other organisations within other countries. The most well-known respirator is the N95. However, respirators can also be KN95, KF94, FFP2, P2 or otherwise. These standards are roughly equivalent, but they are used in different regions. 

 

The easiest way to tell if a device is a respirator is to see if it has the required markings. These markings should have the standard the device adheres to and other information. We put together an article explaining every respirator's required markings to ensure that you aren't choosing a counterfeit device. 

 

There are many different standards of respirators. The lowest filtration devices are FFP1, P1 and KF80, and these devices offer protection against > 80% of fine particles. However, they perform far below the next tier of devices. In the next group, there are devices that offer > 94% or > 95% filtration. In this group, you will find N95, KN95, KF94, FFP2 and P2 devices.

 

These devices are usually the sweet spot for comfort and protection. With respirators, an increase in filtration will typically lead to a decrease in breathability. This is because filter media is often thickened or made denser to catch more particles. Where KF80 devices provide high breathability, they provide this at the expense of filtration. On the other hand, a KF99 device will likely have far lower breathability and be less comfortable to wear.

 

That brings us to the third level of respirators. These are the devices that offer > 99% filtration. You will find N99, FFP3, P3, KN100, and KF99 devices in this category. However, NIOSH offers one level higher in its N100 standard, which provides > 99.97% filtration. 

 

These devices are considered respirators as they have undergone laboratory testing to prove their filtration efficiency, among other tests. In the case of NIOSH devices, they have then been tested by the organisation itself to ensure that they meet the specifications of the standard.

 

It's important to note that respirators are designed to be used with fit testing. Fit testing is a procedure that professionals must undergo before using a respirator to ensure that it fits correctly. Since an ill-fitting respirator provides substantially less protection, it's essential that fit testing is regularly carried out. 

 

However, for most people, we don't have access to professional fit testing. Therefore, while we can make sure that the device is fitted as best possible, the protection factor of respirators is based on the assumption that the wearer has undergone fit testing. 

 

The exception to this rule is public or general-use devices. Respirators such as KF94 and KN95s are designed to be used by the public, and both countries have parallel standards and tiers for medical devices. Where the medical devices are created with fit testing in mind, KF94 and KN95 devices are designed to be used more widely and by people without access to fit testing.

 

Therefore, while fit-testing will always ensure the best fit, KF94 and KN95 devices tend to fit a wider variety of people and require more minor adjusting. Of course, a fit-tested device will always provide better protection than a non-fitted respirator.

At AirPop, our Light SE and Pocket respirators are designed to provide high filtration as per the KN95 certification while not sacrificing fit. For this reason, both devices expand on the typical wire nosepiece and instead include a silicone seal (Light SE) and memory foam (Pocket and Kids).

 

Although wire nosepieces have been the status quo of masks and respirators for many years, they are far from ideal. They are often either too flimsy or sturdy to provide a good seal. After scanning over 4000 faces from individuals worldwide, we innovated the mask to create a seal that fits everyone. 

 

It is also worth noting that there are other forms of respirators. While we only discussed respirators designed to filter particulate matter in this section, there are also respirators designed to filter oily mists and oil-based particles. These respirators follow different naming standards and usually have an R or P in their name. Some examples are KP100, R95 and P100.

 

For everyday use, these devices will not benefit the wearer. They are not needed for COVID-19 and most air pollution use-cases. The one exception is if you are looking for a respirator to use when biking or walking alongside busy roads or highways. It may be worth investing in an R or P respirator in these cases.

 

A final note about respirators is that there are multiple types. Filtering facepiece respirators are the devices you will encounter most commonly - they are smaller, disposable, and common everywhere. However, there are also half-face respirators and full-face respirators.

 

These devices are usually made out of plastic and silicone, and they use replaceable cartridge filters. Half-face and full-face respirators are designed to be used in the most polluted and hazardous environments and are most commonly found in occupational settings such as industrial sites.


Conclusion

COVID-19 rapidly changed the world of masks. With so much attention suddenly placed on the devices, it became common to see words and terms thrown around. Unfortunately, however, many of these terms have become ambiguous and not clearly defined along the way. 

 

This issue is expanded because many media outlets and other news sources misuse the terms or use them in confusing ways. Luckily, the past few months have seen the terminologies become more consistent and accurate.

 

To summarise this article: cloth masks and face covers are masks or clothing items that have undergone no lab testing and rely on (often) homemade materials. While these masks provide some level of protection, surgical masks tend to offer more. 

 

However, surgical masks cannot filter fine particles and are better at catching exhaled droplets from the wearer. A respirator is best for anyone wanting protection from these fine particles or for anyone seeking the utmost protection. 

 

Respirators are the highest performing devices that are designed to seal on the wearer’s face and provide two-way filtration. Although these devices are performant, they do require a leak-free seal in order to provide the advertised filtration. 

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